1. Field of the Invention
The present invention relates to collection devices for recovering samples of bodily fluids or cells for subsequent laboratory analysis and, more particularly, to a collection device and method for allowing the patient to recover samples of bodily fluids, secretions, cells, and infectious and noninfectious agents, in whole all hereinafter referred to as bodily substances, and, for instance, to a modified sanitary napkin for collecting such substances from the genital, anal or urinary regions, and to a method associated with the use thereof.
2. Description of Prior Art
U.S. Pat. No. 5,231,992 issued on Aug. 3, 1993 to Leon discloses a low-impact cervical cell and fluid collector which includes a substantially disc-shaped main body 12 which defines a generally concave recess 14 into which a porous collection membrane 16 is mounted. Therefore, when the collector 10 is in place adjacent to the patient""s cervix, cells and fluids adhere to the outer surface of the membrane 16. Underneath the membrane 16, there is provided a layer 24 of a cell-moistening material or agent, such as a polymer gel adapted to release water during cell collection for moistening collected cells through the pores of the membrane 16 when the cells are adhered to the outer surface thereof. The main body 12 can be provided with a string 18 to facilitate the removal of the collector 10 from the body.
French Patent Application which was published as FR-2 599 500 on Dec. 4, 1987 in the name of Chieusse discloses a transparent adhesive strip for taking a sample directly from the skin""s surface for microscopic examination or analysis, the adhesive strip comprising a rigid transparent resin or glass plate 1 covered successively with a transparent layer 2 which is self-adhesive on both of its sides, an isolating film or coating 4 of shorter length, and a semi-rigid cover layer 3 made, for instance, of strong paper or cardboard. The limited length of the film 4 defines a section 5 where the cover layer 3 adheres directly to the adhesive 2 and forms a joint line 6 which allows for the cover layer 3 to be pivotally lifted about the hinge 6, wherein in a closed position 7, the sample-taking surface 9 is protected for its transport or storage, whereas in its open position 8, the adhesive surface 2 can be brought into direct contact with the skin""s surface such as to enable the adhesive strip 2 to remove and collect desired samples from the skin and other surfaces for subsequent analysis thereof.
U.S. Re-Issue Pat. No. RE 24,666 issued on Jul. 7, 1959 to Draghi discloses a tampon for the detection of cancer of the pelvic region. More particularly, the tampon of this U.S. patent constitutes a preliminary diagnosis method which determines if there are present any indicia of cancer by taking a sample of cells which are present in the cervical canal and in the vagina and by the subsequent microscopic analysis of these cells. The tampon includes a tampon body 10 partly covered by a jacket 12 terminating with an enlarged cap 13 and, at the other end of the tampon body 10, there is provided a string 22. The assembly of the body 10 and jacket 12 forms a detection tampon 14. The enlarged cap 13 which closes one end of the tampon 14 is adapted to extend farthest into the vaginal canal and to collect and retain in moist form cells thereof. The jacket 12 also collects cells and retains them in a relatively moist condition thereby ensuring a more accurate clinical evaluation.
U.S. Pat. No. 3,850,160 issued on Nov. 26, 1974 to Denson discloses a diagnostic tampon 10 having a supporting body 13 covered by an outer film 12 and provided at one end thereof with a removal string 11. The tampon is particularly adapted for collecting cellular material from body cavities, in particular from the vaginal cavity, for subsequent examination.
U.S. Pat. No. 5,432,097 issued on Jul. 11, 1995 to Yourno teaches a method for the recovery of blood cells from dried blood spots on a filter paper.
U.S. Pat. No. 5,119,828 issued on Jun. 9, 1992 to Miller discloses a device 10 for collecting sebum which is secreted by the sebaceous glands of a patient, the device 10 including a microporous film 12 which is opaque to light when the pores are filled with gaseous material and which is substantially translucent when the film pores are filled with sebum. The film 12 is mounted to a substrate 14 which defines a light absorbing area 16 for enhancing visualization of the pores of the film 12 when filled with sebum. In use, the device is pressed against the patient""s skin surface such that the film 12 contacts the skin and absorbs its sebum, whereby a sebum spot pattern is developed in the film 12 and is visually enhanced by way of the light absorbing area 16.
U.S. Pat. No. 5,088,502 issued on Feb. 18, 1992 to Miller discloses a device 10 for sampling the surface of the skin which includes a substrate 12 having a light absorbing area 14 disposed thereon with an adhesive layer 16 being disposed on the substrate 12 such as to overlie the light absorbing area 14. The adhesive layer 16 is optically clear and under pressure conforms to the surface of the skin to be sampled. A removable protective film 18 provided with a tab 20 is disposed on the adhesive layer 16 for protecting the same prior to use of the device. The device and, more particularly, the adhesive layer 16 is placed against the skin surface such that, when removed, skin cells adhere to the adhesive layer 16. The sampled cells can then be visualized in view of the light absorbing area 14.
U.S. Pat. No. 4,789,629 issued on Dec. 6, 1988 to Baker et al teaches a device for collecting and testing fecal occult blood which includes a pocket-like member 16 and an absorbent insert 24 disposed in the pocket member 16. The pocket member 16 is disposed on the inside front cover of the device such that when the cover is in a closed position thereof, the pocket 16 overlies the fecal smear on the specimen receiving sheet 36, whereby with one single collection, two separate membranes, that is the specimen receiving sheet 36 and the absorbent insert 24, receive the components of the fecal sample and can be individually and independently tested.
U.S. Pat. No. 4,808,379 issued on Feb. 28, 1989 to Wardlaw et al discloses a device for obtaining stool samples and detecting occult blood and which is used in a way similar to toilet tissue to obtain a stool sample on a receptor sheet 26 provided in the device. Therefore, to obtain the stool sample, the patient, after defecation, draws the cover sheet 32 and its holes 34 across the rectum in the same manner as toilet tissue such that stool is thus wiped onto the cover sheet and passes through the openings 34 and deposits in spots on the receptor sheet 26. The cover sheet 32 is then peeled off and discarded, thereby exposing the stool spots S of the receptor sheet 26, after which the stool spots S can be effectively sealed in the device by folding the impermeable sheet 2.
It is therefore an aim of the present invention to provide an improved device for allowing a patient to collect externally from the body samples of bodily substances, such as fluids, cells, tissues, microorganisms, etc.
It is also an aim of the present invention to provide an improved method for allowing a patient to collect externally from the body samples of bodily substances, such as fluids, cells, tissues, microorganisms, etc.
It is a further aim of the present invention to provide a modified sanitary napkin for collecting samples of bodily substances from the genital, anal or urinary regions and, for instance, vaginal secretions.
It is a still further aim of the present invention to provide a modified sanitary napkin provided with an absorbent layer for collecting the samples of bodily substances from the genital, anal or urinary regions.
It is a still further aim of the present invention to provide a collection device, such as a modified sanitary napkin, having a removable collection strip, membrane or filter, in particular in the form of an absorbent strip, slidably received in a pocket defined in the collection device or sanitary napkin.
Therefore, in accordance with the present invention, there is provided a collection device for collecting bodily substances from the genital, anal or urinary regions, comprising a substantially flexible and comfortable member adapted to be positioned such that a receiving surface of said member is located substantially opposite a location from which a sample of bodily substance is to be taken, collecting means in said member and in communication with said receiving surface, whereby sufficient bodily substance contacting said receiving surface is at least partly collected by said collecting means for subsequent analysis thereof.
Also in accordance with the present invention, there is provided a collection device for allowing a user to collect bodily substances, comprising a member adapted to be externally worn by the user such that a receiving surface of said member is located substantially opposite a location of the user at which a sample of bodily substance is to be taken, collecting means in said member and in communication with said receiving surface, said collecting means being removable from said member by the user, whereby once sufficient bodily substance having contacted said receiving surface has been at least partly collected by said collecting means, said collecting means is removed from said member for subsequent analysis thereof.
Further in accordance with the present invention, there is provided a method of self-collection of bodily substances, comprising the steps of:
(a) self-positioning collector means externally on a user and at a location of the user at which a sample of bodily substance is to be taken; and
(b) collecting on said collector means at least one bodily substance from the user.